Method of Dispensing A Test Strip

ABSTRACT

In one aspect, a method of dispensing a test strip is provided in which the dispensed test strip remains stationary while the inner housing moves within an outer housing. In another embodiment, a test strip dispenser is provided that dispenses one test strip at a time. The test strip dispenser includes a movable inner housing nested inside an outer housing. A test strip dispensing system is also described.

Apparatuses and methods for measuring components of biological fluids aswell as test strips for use in such devices are well known. Typically,the test strips are stored in a disposable container that is separatefrom the apparatus that measures the fluid component of interest. In theknown test strip system, a test strip is removed from the container, afluid sample is dispensed onto the strip, and the strip is inserted intoa photometric or electrochemical meter for analysis of the desiredcomponent. After analysis is completed, the test strip is extracted fromthe meter and the strip is discarded.

Ease of use of hand held test strip dispensers and meters is important,particularly for those dispensers that will be used by persons withdiminished hand-eye coordination or finger sensation. For example,persons with diabetes typically have either or both impaired vision anddiminished fingertip sensation. Such persons must use test strips andmeters to test their blood glucose levels a number of times a day.However, the typical test strip is only several millimeters in width andlength and, thus, difficult to manipulate. Additionally, conventionalstrips are typically packed in small, cylindrical containers from whichit is difficult to easily extract a single strip.

Accordingly, applicants heretofore provide for an invention thatameliorates the drawbacks of the known test strip and associatedcomponents discussed above. In one aspect, a method of dispensing a teststrip is provided in which the dispensed test strip remains stationarywhile the inner housing moves within an outer housing. The method can beachieved by providing a plurality of test strips disposed in a teststrip dispenser having a housing and a meter having a strip port;coupling the strip port of the meter with the housing of the test stripdispenser; moving the housing along a guide member from a first positionto a second position while holding a first test strip stationary; andremoving the first test strip from the outer housing.

These and other embodiments, features and advantages will becomeapparent to those skilled in the art when taken with reference to thefollowing more detailed description of the invention in conjunction withthe accompanying drawings that are first briefly described herebelow.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutepart of this specification, illustrate presently preferred embodimentsof the invention, and, together with the general description given aboveand the detailed description given below, serve to explain features ofthe invention (wherein like numerals represent like elements), of which:

FIGS. 1A, 1B and 1C are perspective, exploded and partially explodedviews, respectively, of a test strip dispenser according to an exemplaryembodiment;

FIGS. 2, 3 and 4 are cross-sectional views of the test strip dispenserillustrated in FIG. 1A;

FIG. 5 is a perspective partial cross-sectional view of the outerhousing of the test strip dispenser shown in FIGS. 1A-1C;

FIGS. 6 and 7 are perspective partial cross-sectional views of the outerhousing of a test strip dispenser according to other exemplaryembodiments.

FIG. 8A is a perspective close up view of the first end of the innerhousing of the test strip dispenser shown in FIGS. 1A-1C;

FIG. 8B is a perspective close up view of the proximal end of the innerhousing of the test strip dispenser shown in FIGS. 1A-1C;

FIGS. 9A-9D are schematic partial cross-sectional side views of asequence of steps used in a process for dispensing a test strip from atest strip dispenser to a test position in a meter;

FIGS. 10A-10C are schematic cross-sectional top views of a sequence ofsteps used in an anti-jamming process;

FIGS. 11A-11C are perspective, exploded and partially exploded views,respectively, of a test strip dispenser;

FIGS. 12 and 13 are cross-sectional views of the test strip dispensershown in FIGS. 11A-11C;

FIG. 14 is a perspective, partial cross-sectional view of the outerhousing of the test strip dispenser shown in FIGS. 11A-11C;

FIG. 15 is a perspective view of the first end of the inner housing ofthe test strip dispenser shown in FIGS. 11A-11C;

FIG. 16 is a close up perspective view of the inner surface of thesecond portion of the inner housing shown in FIG. 11B;

FIGS. 17A-17D are schematic partial cross-sectional side views of asequence of steps used in a process for dispensing a test strip from atest strip dispenser to a test position; and

FIG. 18 is a close up perspective view of the inner surface of thesecond portion of the inner housing shown in FIG. 11B illustrating thelocation of a test strip being dispensed during a test strip dispensingprocess.

DETAILED DESCRIPTION

Various exemplary embodiments disclosed herein includes test stripdispensing methods and devices suited for storage or delivery of a widevariety of electrochemical test strips and photometric test strips, suchas test strips suitable for use in the determination of analytes inwhole blood or derivatives thereof. In one aspect, the test strip canstore a plurality of such test strips and can dispense individual teststrips for receipt by a diagnostic device known as in the art as a“meter.” Also disclosed herein are test strip dispensing systems thatinclude a meter configured to mate with the test strip dispenser and toreceive test strips therefrom.

It is noted that the following detailed description should be read withreference to the drawings, in which like elements in different drawingsare identically numbered. The drawings, which are not necessarily toscale, depict selected embodiments and are not intended to limit thescope of the invention. The detailed description illustrates by way ofexample, not by way of limitation, the principles of the invention. Thisdescription will clearly enable one skilled in the art to make and usethe invention, and describes several embodiments, adaptations,variations, alternatives and uses of the invention, including what ispresently believed to be the best mode of carrying out the invention.

FIGS. 1A-1C and FIGS. 2-4 illustrate a test strip dispenser 100according to an exemplary embodiment. Test strip dispenser 100 includesa proximal end 102, a distal end 104, an outer housing 106 and an innerhousing 108. Inner housing 108, which is configured to house a pluralityof test strips 200 (e.g., a stack of test strips), is nested insideouter housing 106 and is moveable therein. Outer housing 106 and innerhousing 108 are generally rectangular in shape and may be formed of asuitable material, preferably such as, for example, acrylonitrilebutadiene styrene, polycarbonate or combinations thereof.

Each of the plurality of test strips 200 that can be used with variousembodiments described and illustrated herein are generally elongate inshape and are sized to fit within inner housing. In the illustratedembodiment, test strip 200 can be, for example, a OneTouch® Ultra® brandglucose test strip or other suitable test strips that are commerciallyavailable.

Each of the plurality of test strips 200 is usually stored in test stripdispenser 100 with the distal end on which a fluid sample is appliedextending toward distal end of test strip dispenser 100 and, forelectrochemical type test strips, with the proximal end containingelectrical connects extending toward proximal end of test stripdispenser 100. This ensures that when a single test strip is removedfrom test strip dispenser 100 by a meter, the test strip will be in acorrect orientation for applying the fluid sample and, forelectrochemical type test strips, for making an electrical connectionwith the meter.

Referring to FIGS. 1A-1C, outer housing 106 includes a first member 110and a second member 112. Second member 112 includes an opening 114 forgaining access to test strip 200 stored in inner housing 108. Firstmember 110 and second member 112 are joined together by, for example, asnap fit or ultrasonic welding to form a space for holding inner housingtherein.

As illustrated in FIGS. 2 and 5, outer housing 106 further includes aguide member 116 on a first inner surface 118, a first recess 120 on asecond inner surface 122 and an optional second recess 124 on a thirdinner surface 126. Guide member 116 includes a ledge 128 and a stop 130on a proximal end 136 and a surface 132 on which inner housing 108moves. Guide member 116 optionally includes a first spring locator 134on proximal end 136. In one embodiment illustrated in FIG. 5, the crosssection of guide member 116 is t-shaped. In other embodiments shown inFIGS. 6 and 7, guide member 116 may be a modified t shape in which aleft or right arm, respectively, is removed.

Referring to FIGS. 1B, 1C and 2, inner housing 108 includes a proximalend 138, a distal end 140, a first side 142, a second side 144, a firstend 146 and a second end 148. Proximal end 138 of inner housing 108includes a projection 150 with an aperture 152 through which a teststrip travels during dispensing. Projection 150 is oblong in shape andis configured to fit within opening 114 in outer housing 106.

Inner housing 108 is biased toward proximal end 102 of test stripdispenser 100 by a spring 154. Spring 154 may be located proximal toguide member 116, as shown in FIG. 2, or may be located distal toproximal end 138 of inner housing 108 as illustrated in FIG. 12. Havingspring 154 located proximal to guide member 116 results in a morecompact test strip dispenser 100. When spring 154 is located proximal toguide member 116, a second spring locator 156 is optionally located on afirst side 160 of a protrusion 162 on first end 146 of inner housing 108(see FIGS. 2 and 8A).

As illustrated in FIGS. 8A and 8B, inner housing 108 further includes agroove 158 at first end 146 that mates with and moves on guide member116 on first inner surface 118 of outer housing 106 during test stripdispensing, as will be described in more detail with reference to FIGS.9A-9D. In one embodiment shown in FIGS. 8A and 8B, groove 158 ist-shaped and spans about one fourth of the distance from distal end 140to proximal end 138 of inner housing 108. Although groove 158 isillustrated as having a “T” cross-section, groove 158 may be of anyshape compatible with the shape of guide member 116 as long as thegroove 158 mates and moves on guide member 116.

As illustrated in FIGS. 1B, 2 and 3, a spring-loaded platform 164 biasesplurality of strips 200 toward first end 146 of inner housing 108. Anexample spring used to bias platform 164 is a spiral spring 166. A firstend 168 of spiral spring 166 may be held in place in a slot 170 nearfirst end 146 of inner housing 108 (see FIG. 1B). Alternatively, firstend 168 of spiral spring 166 may be coupled near first end 146 of innerhousing 108 by a suitable process such as, for example, plastic welding,bonding, or preferably heat staking. A second end 172 of spiral spring166 forms a spiral that resides in a niche 174 in platform 164. Toaccommodate a suitable fit of plurality of test strips 200 within innerhousing 108, spiral spring 166 may optionally extend through alongitudinal space 176 in first side 146 of inner housing 108.

Inner housing 108 further includes an anti-jamming mechanism having atleast one flipper 180 with a first end 182 and a second end 184, asillustrated in FIG. 4. First end 182 of at least one flipper 180 ispivotally attached to first side 142 of inner housing 108 with, forexample, a hinge 186. Second end 184 of at least one flipper 180includes an arm 188 that engages a sloping surface 190 of first recess120 of outer housing 106 if a test strip is not engaged by a meterduring test strip dispensing, as will be described with reference toFIG. 10C.

Referring to FIGS. 9A-9D and 10A-10C together, a sequence of steps in amethod for dispensing a test strip is illustrated. The provision of anexemplary test strip dispenser that may be used with the subject methodis depicted in FIGS. 1A-1C, 2-4 and 8A-8B in which like elements of thetest strip dispenser of the earlier figures are identified with likenumerals.

In the first step of the subject method, test strip dispenser 100housing plurality of test strips 200 and a meter 220 are providedaccording to exemplary embodiments (see FIGS. 9A and 10A). Prior to afirst test strip 202 being dispensed, test strip dispenser 100 is in arest position in which groove 158 of inner housing 108 rests on surface132 of guide member 116 and plurality of test strips 200 rests on ledge128 of guide member 116.

As illustrated in FIGS. 9B and 10B, a strip port 222 of meter 220 isthen inserted into opening 114 of outer housing 106 and strip port 222engages with projection 150 of inner housing 108, urging inner housing108 toward distal end 104 of test strip dispenser 100 along guide member116. While inner housing 108 is urged along guide member 116, first teststrip 202 remains substantially stationary while the remaining pluralityof test strips 200 moves toward distal end 104 of test strip dispenser100. As inner housing 108 is urged along guide member 116, the proximalend of first test strip 202 engages incline of second end 184 of atleast one flipper 180, pushing at least one flipper 180 laterallyoutward and toward the inner walls of outer housing 106. Inner housing108 continues to be urged along guide member 116 until it is pushedtoward distal end 104 of test strip dispenser 100 as far as possible, atwhich time the distal end of first test strip 202 is engaged with stop130 of guide member 116 and the proximal end of first test strip 202 isengaged with a strip port connector 224 of meter 220, as illustrated inFIGS. 9B and 10B. It should be noted that the height of stop 130 isusually slightly smaller than the thickness of the test strip so thatonly one test strip at a time is engaged with stop 130. At this point,arm 188 on second end 184 of the at least one flipper 180 moves freelywithin first recess 120 of outer housing 106.

As strip port 22 is removed from opening 114 of outer housing 106 withfirst test strip 202 engaged in strip port connector 224, first teststrip 202 is pulled through aperture 152 in projection 150 of innerhousing 108, and inner housing 108 is biased toward proximal end 102 oftest strip dispenser 100 (see FIG. 9C). It should be noted that aperture152 is sized to accommodate only one test strip at a time. As soon asthe distal end of first test strip 202 enters aperture 152, a secondtest strip is biased by platform toward first end 146 of inner housing108 into a dispensing position (not shown). If strip port connector 224does not engage with first test strip 202, arm 188 of at least oneflipper 180 engages with sloping surface 190 in first recess 120 ofouter housing 106, preventing inner housing 108 from moving back to therest position and preventing the distal end of a second test strip fromengaging with stop 130 of guide member 116 (see FIG. 10C). Inner housing108 remains locked in this anti-jamming position until the meter isurged against inner housing 108 again and strip port connector 224engages first test strip 202.

As illustrated in FIG. 9D, first test strip 202 is completely removedfrom test strip dispenser 100 while remaining engaged in strip portconnector 224 of meter 220 and is positioned for testing.

FIGS. 11A-11C and FIGS. 12-16 illustrate a test strip dispenser 300according to another exemplary embodiment. Test strip dispenser 300includes a proximal end 302, a distal end 304, an outer housing 306 andan inner housing 308. Inner housing 308, which is configured to house aplurality of test strips 400 (e.g., a stack of test strips), is nestedinside outer housing 306 and is moveable therein. Outer housing 306 andinner housing 308 are generally rectangular in shape and may be formedof a suitable material, preferably such as acrylonitrile butadienestyrene, polycarbonate or combinations thereof.

Each of the plurality of test strips 400 that can be used with variousembodiments described and illustrated herein are generally elongate inshape and are sized to fit within the inner housing. In the illustratedembodiment, test strip 400 can be, for example, a glucose test strip asshown and described in U.S. Pat. No. 6,749,887, which is herebyincorporated in full by reference. Alternatively, the other suitablecommercially available test strips may also be used with variousembodiments described and illustrated herein.

Each of the plurality of test strips 400 is usually stored in test stripdispenser 300 with the distal end on which a fluid sample is appliedextending toward distal end 304 of test strip dispenser 300 and, forelectrochemical type test strips, with the proximal end containingelectrical connections extending toward proximal end 302 of test stripdispenser 300. This ensures that when a single test strip is removedfrom test strip dispenser 300 by a meter, the test strip will be in acorrect orientation for applying the fluid sample and, forelectrochemical type test strips, for making an electrical connectionwith the meter.

Referring to FIGS. 11A-11C, outer housing 306 includes a first member310 and a second member 312 with an opening 314 for gaining access to atest strip stored in inner housing 308. First member 310 and secondmember 312 are joined together by, for example, ultrasonic welding or asnap fit to form a space for holding inner housing 308 therein. Asillustrated in FIGS. 12-14, outer housing 306 further includes a guidemember 316 on a first inner surface 318 and an optional spring locator334 on a second inner surface 320. In one embodiment, guide member 316is t-shaped and includes a ledge 322, a stop 324 on a proximal end 336and a surface 326 on which inner housing 308 moves. In otherembodiments, guide member 316 may be a modified t shape in which a leftor right arm, respectively, is removed (not shown).

Referring again to FIGS. 11B-11C, inner housing 308 includes a firstportion 330 and a second portion 332 joined together by, for example,screws or ultrasonic welding to form a cavity configured to houseplurality of test strips 400. Inner housing 308 may also be formed of asingle molded body. As shown in FIG. 11C, in assembled form, innerhousing includes a proximal end 338, a distal end 340, a first side 342,a second side 344, a first end 346 and a second end 348. Proximal end338 of inner housing 308 includes a projection 350 with an aperture 352through which a test strip travels during dispensing. Projection 350 isoblong in shape and is configured to fit within opening 314 in outerhousing 306.

Inner housing 308 is biased toward proximal end 302 of test stripdispenser 300 by a spring 354. Spring 354 is located distal to proximalend 338 of inner housing 308 as illustrated in FIG. 12. Inner housing308 may optionally include a recess 356 on distal end 340 for locatingan end of spring 354 (see FIGS. 12 and 15).

As illustrated in FIG. 15, inner housing 308 further includes a groove358 at first end 346 that mates with and moves on guide member 316 onfirst inner surface 318 of outer housing 306 during test stripdispensing, as will be described in more detail with reference to FIGS.17A-17D. In one embodiment illustrated in FIG. 15, groove 358 may bet-shaped and spans the length of first end 346 of inner housing 308.Alternatively, the groove 358 may be any shape compatible with the shapeof guide member 316.

As illustrated in FIG. 16, inner housing 308 further includes a firstshelf 360 on which plurality of test strips 400 rests before and duringtest strip dispensing and a second shelf 362 on a first inner surface364 in which a test strip being dispensed drops during test stripdispensing. Additionally, inner housing 308 includes an arm 366projecting from a second inner surface 368 near proximal end 338 ofinner housing 308 that engages the plurality of test strips 400 notbeing dispensed during the dispensing process, as will be describedbelow. Arm 366 also forms one side of a channel 367 through which onlyone test strip at a time can move. The other side of channel 367 isformed by second shelf 362.

Referring again to FIGS. 11B, 12 and 13, a spring-loaded platform 370biases plurality of strips 400 toward first end 346 of inner housing308. An example spring used to bias platform is a spiral spring 372. Afirst end 374 of spiral spring 372 may be held in place in a slot 376near first end 346 of inner housing 308. Alternatively, first end 374 ofspiral spring 372 may be affixed near first end 346 of inner housing 108by a process such as heat staking. A second end 378 of spiral spring 372forms a spiral that resides in a niche 380 in platform 370. Toaccommodate a snug fit of plurality of test strips 400 within innerhousing 308, spiral spring 372 may optionally extend through alongitudinal space (not shown) in first side 346 of inner housing 308.

Inner housing 308 may optionally include a window 382 in first side 342or second side 344 for viewing the number of test strips remaining ininner housing 308 (see FIG. 11B). Alternatively, both the inner andouter housings may be formed of a generally transparent material or evena translucent material to allow for visualization of the number of teststrips remaining in the dispenser.

Referring to FIGS. 17A-17D and FIG. 18 together, a sequence of steps ina method for dispensing a test strip. The provision of an exemplary teststrip dispenser that may be used with the subject method is depicted inFIGS. 11A-11C and 12-16 in which like elements of the test stripdispenser of the earlier figures are identified with like numerals.

In the first step of the subject method, test strip dispenser 300housing plurality of test strips 400 and a meter 420 are providedaccording to exemplary embodiments (see FIG. 17A). Prior to a first teststrip 402 being dispensed, test strip dispenser 300 is in a restposition in which a portion of groove 358 of inner housing 308 rests onsurface 326 of guide member 316 and plurality of test strips 400 restson first shelf 360 in first inner surface 364 of inner housing 308 (seeFIG. 18 for first shelf 360).

As illustrated in FIG. 17B, a strip port 432 of meter 420 is theninserted into opening 314 of outer housing 306 and strip port 422engages with projection 350 of inner housing 308, urging inner housing308 toward distal end 304 of test strip dispenser 300 along guide member316. While inner housing 308 is urged along guide member 316, arm 366projecting from second inner surface 368 of inner housing 308 engagesall of the plurality of test strips 400 except first test strip 402. Atthis step, first test strip 402 remains substantially stationary whilethe remaining plurality of test strips 400 moves toward distal end 304of test strip dispenser 300. Inner housing 308 continues to be urgedalong guide member 316 until it is pushed toward distal end 304 of teststrip dispenser 300 as far as possible, at which time first test strip402 drops onto second shelf 362 on first inner surface 364 of innerhousing 308 and the distal end of first test strip 402 is engaged withstop 324 of guide member 316 (see FIGS. 17B and 18). At or near the sametime the distal end of first test strip 402 is engaged with stop 324 ofguide member 316, the proximal end of first test strip 402 is engagedwith a strip port connector 424 of meter 420. First test strip 402 dropsonto second shelf 362 to release pressure on the remaining plurality oftest strips 400 moving toward distal end 304 of test strip dispenser 300and to lessen the retention force required by strip port connector 424.

Referring to FIG. 17C, as strip port 422 of meter 420 is removed fromopening 314 of outer housing 306 with first test strip 402 engaged instrip port connector 424, first test strip 402 is pulled through channel367 and then is pulled through aperture 352 in projection 350 of innerhousing 308. As first test is pulled through channel 367 and aperture352, inner housing 308 is biased toward proximal end 302 of test stripdispenser 300.

As illustrated in FIG. 17C, first test strip 402 is completely removedfrom test strip dispenser 300 while remaining engaged in strip portconnector 424 of meter 420 and is positioned for testing.

While the invention has been described in terms of particular variationsand illustrative figures, those of ordinary skill in the art willrecognize that the invention is not limited to the variations or figuresdescribed. In addition, where methods and steps described above indicatecertain events occurring in certain order, those of ordinary skill inthe art will recognize that the ordering of certain steps may bemodified and that such modifications are in accordance with thevariations of the invention. Additionally, certain of the steps may beperformed concurrently in a parallel process when possible, as well asperformed sequentially as described above. Therefore, to the extentthere are variations of the invention, which are within the spirit ofthe disclosure or equivalent to the inventions found in the claims, itis the intent that this patent will cover those variations as well.Finally, all publications and patent applications cited in thisspecification are herein incorporated by reference in their entirety asif each individual publication or patent application were specificallyand individually put forth herein.

1. A method of dispensing a test strip, the method comprising: providinga plurality of test strips disposed in a test strip dispenser having ahousing and a meter having a strip port; coupling the strip port of themeter with the housing of the test strip dispenser; moving the housingalong a guide member from a first position to a second position whileholding a first test strip stationary; and removing the first test stripfrom the housing.
 2. The method of claim 1, wherein the housingcomprises an inner housing located inside an outer housing.
 3. Themethod of claim 2, wherein the coupling comprises engaging the stripport connector to the inner housing.
 4. The method of claim 2, whereinthe moving the inner housing step comprises biasing the inner housingalong a linear path.
 5. The method of claim 2, further including biasingthe inner housing toward the opening in the outer housing to move asecond test strip into a dispensing position.
 6. The method of claim 4,wherein the inner housing is biased along a linear path.
 7. The methodof claim 2, wherein the providing comprises: stacking the plurality oftest strip face to face from an upper surface to a bottom surface in theinner housing; and biasing the plurality of test strips towards thebottom surface.
 8. The method of claim 6, wherein the moving comprisespreventing the inner housing from moving towards the first position whenthe strip port connector fails to engage with the first test strip. 9.The method of claim 2, wherein the providing comprises forming a windowin the inner housing to allow for visual determination of the number ofstrips disposed in the inner housing.
 10. The method of claim 2, whereinthe providing comprises forming the inner and outer housing of agenerally transparent material.
 11. The method of claim 1, wherein thetest strip dispenser comprises: an inner housing having an interiorvolume to store a plurality of test strips, the inner housing having anaperture through which a test strip is dispensed, the inner housingincluding a groove, a spring that biases the inner housing in a firstdirection; and an outer housing having an opening in substantialalignment with the aperture of the inner housing to allow for passage ofthe test strip, the outer housing having a guide member that mates withthe groove of the inner housing.